US Food and Drug Administration review of statistical analysis of patient-reported outcomes in lung cancer clinical trials approved between January, 2008, and December, 2017-Reference-Cited by-同舟云学术

US Food and Drug Administration review of statistical analysis of patient-reported outcomes in lung cancer clinical trials approved between January, 2008, and December, 2017

Published:2019-10 Issue:10 Volume:20 Page:e582-e589
ISSN:1470-2045
Container-title:The Lancet Oncology
language:en
Short-container-title:The Lancet Oncology

Author:

Fiero Mallorie H,Roydhouse Jessica K,Vallejo Jonathon,King-Kallimanis Bellinda L,Kluetz Paul G,Sridhara Rajeshwari

Publisher

Elsevier BV

Subject

Oncology

Reference42 articles.

1. Analysing data from patient-reported outcome and quality of life endpoints for cancer clinical trials: a start in setting international standards;Bottomley;Lancet Oncol,2016

2. Inclusion of patient-reported outcome measures in registered clinical trials: evidence from ClinicalTrials.gov (2007–2013);Vodicka;Contemp Clin Trials,2015

3. Focusing on core patient-reported outcomes in cancer clinical trials: symptomatic adverse events, physical function, and disease-related symptoms;Kluetz;Clin Cancer Res,2016

4. Informing the tolerability of cancer treatments using patient-reported outcome measures: summary of an FDA and Critical Path Institute workshop;Kluetz;Value Health,2018

5. Quality of life: the assessment, analysis and interpretation of patient-reported outcomes;Fayers,2013

Cited by 32 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Statistical Analysis Methods and Reporting of Patient-Reported Outcomes in Randomized Controlled Trials for Cancer Conducted in Japan: A Systematic Review;Cureus;2024-05-21

2. Improvements in the health-related quality-of-life benefit of cancer drugs approved in China, 2005–2020: an observational study;The Lancet Regional Health - Western Pacific;2024-05

3. [Special issue PRO] Considering endpoints for comparative tolerability of cancer treatments using patient report given the estimand framework;Journal of Biopharmaceutical Statistics;2024-02-15

4. 15 years of patient-reported outcomes in clinical trials leading to GU cancer drug approvals: a systematic review on the quality of data reporting and analysis;eClinicalMedicine;2024-02

5. A Visual Analysis of Patient-Reported Outcomes in Lung Cancer From 2013 to 2023;Cancer Control;2024-01